HOE — Caliper, Ophthalmic Class I
FDA product code HOE covers "Caliper, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HOE
- Device Class
- Class I
- Regulation Number
- 886.4350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K881094 | coopervision | KOI(TM) BLADE GAUGE, MODEL KOI-132 | April 1, 1988 |
| K813315 | design research assoc | CALIPER-OPTHALMIC | March 1, 1982 |
| K820050 | accutome | KREMER BLADE GAUGE | February 24, 1982 |
| K812011 | koi | BLADE GAUGE | July 28, 1981 |
| K801937 | aztec medical products | BLEPHAROMETER | September 16, 1980 |
| K792383 | v. mueller o.v. baxter healthcare | KELMAN DIPSTICK | December 11, 1979 |
| K781715 | edward weck | RULER, WECK SCOTT | December 4, 1978 |